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This is a prospective, multicenter, randomized controlled clinical study to evaluate the effect of using intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment. Pyrotinib is a small molecule tyrosine kinase inhibitor that can irreversibly inhibit HER1, HER2, and HER4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intelligent patient management model | Experimental |
| |
| traditional patient management model | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pyrotinib | Drug | Intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| medication adherence at 1-year | medication adherence at 1-year is assessed using the tablet counting method and Eight-Item Morisky Medication Adherence Scale Evaluation Method 1: Tablet Counting Method
At the screening phase and Day 21 of each cycle, calculate the adherence percentage based on APP check-ins, and confirm the actual remaining tablets through follow-up. Evaluation Method 2: MMAS-8 Scale （1）Definition: The Morisky Medication Adherence Scale-8 (MMAS-8) is a validated 8-item questionnaire. The total score ranges from 0 to 8, with higher scores indicating better adherence: 8: Good adherence 6-7: Moderate adherence <6: Poor adherence （2）Procedure: Administer the MMAS-8 scale at the screening phase and Day 21 of each cycle. The total score is calculated as the sum of scores from the 8 questions. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| The time to deterioration (TTD) | TTD is defined as the time from randomization to confirmation of the first clinically significant deterioration (deterioration ≥ 10 points) in subsequent follow-up or death | time from the date of randomization to the date of the first clinically significant deterioration through study completion, an average of 2 year |
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Inclusion Criteria:
Female patients aged ≥ 18 years.
Histologically confirmed HER2-positive breast cancer (IHC 3+ or IHC 2+ with ISH+).
Patients expected to receive pyrotinib-containing regimens for neoadjuvant therapy or metastatic/unresectable breast cancer.
·≤1 prior line of anti-HER2 therapy during the recurrent/metastatic stage.
Ability to operate a mobile phone and read independently.
Deemed psychologically and physically suitable for participation by the investigator.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiani Wang, M.D. | Contact | 86010877-88120 | ncc_wangjiani@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiani Wang, M.D. | National Cancer Center Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33328035 | Result | Koehler F, Koehler K, Prescher S, Kirwan BA, Wegscheider K, Vettorazzi E, Lezius S, Winkler S, Moeller V, Fiss G, Schleder J, Koehler M, Zugck C, Stork S, Butter C, Prondzinsky R, Spethmann S, Angermann C, Stangl V, Halle M, von Haehling S, Dreger H, Stangl K, Deckwart O, Anker SD. Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial. Lancet Digit Health. 2020 Jan;2(1):e16-e24. doi: 10.1016/S2589-7500(19)30195-5. Epub 2019 Dec 12. |
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IPD Description: Individual participant data will not be shared to protect patient privacy. The study involves sensitive clinical and behavioral data, and even de-identified datasets carry residual re-identification risks. Data access is restricted to the research team under ethical and legal obligations.
Access Criteria: N/A IPD Sharing URL: N/A
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randomized controlled clinical study
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| Event-free survival (EFS) | EFS (defined as the time from randomization to the first documentation of progressing disease while on study therapy, postoperative disease recurrence, or death from any cause) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years. |
| Overall survival (OS) | the time from randomisation to death from any cause | From date of randomization until the date of death from any cause, assessed up to 4 years |
| PRO | EORTC QLQ-C30 and NCC-BC-A1.0 questionnaire：
| From date of randomization until the date of death from any cause, assessed up to 4 years |
| ID | Term |
|---|---|
| C000622954 | pyrotinib |
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